Trial Outcomes & Findings for Seasonal Variation of Ambulatory Blood Pressure (NCT NCT01119755)

NCT ID: NCT01119755

Last Updated: 2012-01-23

Results Overview

Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period

• Recruitment status: COMPLETED
• Target enrollment: 80 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2012-01-23

Participant Flow

Participant milestones

Measure	Group 1
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Seasonal Variation of Ambulatory Blood Pressure

Baseline characteristics by cohort

Measure	Group 1 n=80 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants
Age Continuous	64 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment Greece	80 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period

Outcome measures

Measure	Group 1 n=80 Participants
Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.	7.7 mmHg Standard Deviation 14

PRIMARY outcome

Timeframe: 1 year

Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Measurement During Summer and Winter Period

Outcome measures

Measure	Group 1 n=80 Participants
Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter	4.1 mmHg Standard Deviation 10

PRIMARY outcome

Timeframe: 1 year

Mean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period

Outcome measures

Measure	Group 1 n=80 Participants
Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter	-0.1 mmHg Standard Deviation 11.2

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Measure	Group 1 n=80 Participants
Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter	0.6 mmHg Standard Deviation 8.9

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Group 1 n=80 Participants
Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter	7.5 mmHg Standard Deviation 11.1

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Group 1 n=80 Participants
Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter	2.7 mmHg Standard Deviation 7

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Group 1 n=80 Participants
Mean Difference of Systolic Home Blood Pressure Between Summer and Winter	3.2 mmHg Standard Deviation 14

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Measure	Group 1 n=80 Participants
Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter	2.7 mmHg Standard Deviation 4.1

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

George S Stergiou, Associate Professor of Internal Medicine and Hypertension

Hypertension Center, Third Department of Medicine, University of Athens, Greece

Phone: +302107763117

Email: gstergi@med.uoa.gr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place